Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis - Full Text View

Sponsors and Collaborators:	University of Cologne University Hospital, Frankfurt University Hospital Tuebingen
Information provided by:	University of Cologne
ClinicalTrials.gov Identifier:	NCT00465920

Purpose

In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which where especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability. Although CBT addresses the key problems of early onset psychoses (EOP)treatment and first evaluations of CBT in adults with schizophrenia are promising, no experience with CBT in adolescents with EOP are available. Therefore the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size. Patients are randomized to receive either mCBT+TAU or TAU over a 9 month period. mCBT is an individual outpatient treatment of 20 session and 5 psychoeducational sessions with parents. Follow-ups for two years every 6 months are planned.

Condition	Intervention	Phase
Psychotic Disorders Schizophrenia Schizoaffective Disorder Delusional Disorder Schizophreniform Disorder	Behavioral: modified cognitive behavioural therapy (mCBT)	Phase II

MedlinePlus related topics: Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Development and Pilot Evaluation of Modified Cognitive Behavioural Therapy for Adolescents With Early Onset Psychosis

Further study details as provided by University of Cologne:

Primary Outcome Measures:

PANSS positive syndrome (sum of items P1-P7), assessed during the treatment phase (9 month) monthly and during the follow-up phase (2 years) every 6 months

Secondary Outcome Measures:

additional symptom ratings (PSYRATS)
social functioning (GAF)
illness related events (suicide, suicide attempts, rehospitalisation, severe depressive symptom exacerbation)
quality of life (MSLQ)assessed monthly during the treatment phase (9 months) and every 6 months during the follow-up phase (2 years)

Estimated Enrollment:	42
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2010

Eligibility

Ages Eligible for Study:	14 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Schizophrenia, schizophreniform or schizoaffective disorder (DSM IV 295.1- .9), delusional disorder (DSM IV 297.1)
Score of 4 or more on one of the PANSS-items P1, P3, G9
Positive psychotic symptoms for 3 months or more
Age between 14 and 18
Fluently German speaking

Exclusion Criteria:

Diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
Alcohol- or drug dependence according to DSM IV
Verbal IQ < 80
Travel time to the study centre of more than 1 hour

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465920

Contacts

Contact: Andreas Bechdolf, PD Dr.	+49 221 478 3869	andreas.bechdolf@uk-koeln.de
Contact: Bettina Pohlmann, Dr.	+ 49 221 478 3870	bettina.pohlmann@uk-koeln.de

Locations

Germany, North Rhine-Westphalia
Department of Psychiatry University Cologne	Recruiting
Cologne, North Rhine-Westphalia, Germany, 50937
Contact: Andreas Bechdolf, PD Dr. +49 221 478 3869 andreas.bechdolf@uk-koeln.de
Contact: Bettina Pohlmann, Dr. +49 221 478 3870 bettina.pohlmann@uk-koeln.de
Principal Investigator: Andreas Bechdolf, PD Dr.

Sponsors and Collaborators

University of Cologne

University Hospital, Frankfurt

University Hospital Tuebingen

Investigators

Principal Investigator:

Andreas Bechdolf, PD Dr.

University of Cologne

More Information

Study ID Numbers:	01GV0619
Study First Received:	April 25, 2007
Last Updated:	June 14, 2007
ClinicalTrials.gov Identifier:	NCT00465920
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Cologne:

schizophrenia
cognitive behavioural therapy
early onset psychosis
Psychotic disorders (schizophrenia, schizoaffective disorder, delusional disorder, schizophreniform disorder according to DSM IV) in adolescents

Study placed in the following topic categories:

Schizophrenia
Schizophrenia, Paranoid
Delusions
Mental Disorders

Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on January 16, 2009